A Florida man pleaded guilty today to conspiring to defraud the U.S. Food and Drug Administration (FDA) by concealing information about illegal products labeled as dietary supplements.

David Winsauer, 35, of Delray Beach, worked from 2014 to 2018 for Blackstone Labs, LLC, a Boca Raton company that sold products labeled as dietary supplements. According to court filings, Winsauer admitted that he and other co-conspirators worked to portray the company to consumers as complying with applicable federal laws, when in fact, the company arranged to manufacture products that were illegal under federal law. Winsauer admitted that members of the conspiracy also coordinated to conceal sales of products labeled as dietary supplements from the FDA, including by removing information about illegal products from online marketing to create the false impression that they were no longer selling those products. 

“The FDA regulates dietary supplements to protect the health of American consumers,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The Department of Justice will prosecute individuals and companies who undermine that mission by deceiving the FDA.”

“Products mislabeled as dietary supplements can pose a serious risk to the health of U.S. consumers,” said Special Agent in Charge Justin C. Fielder for the FDA Office of Criminal Investigations Miami Field Office. “We will continue to investigate and bring to justice those who jeopardize the public health by selling violative products.”

Winsauer pleaded guilty to conspiracy to defraud the United States in Ft. Lauderdale before U.S. District Judge William P. Dimitrouleas of the Southern District of Florida. He is scheduled to be sentenced on Nov. 12 and faces a maximum penalty of five years in prison.

The FDA’s Office of Criminal Investigations investigated the case.

Blackstone Labs, Winsauer and six other defendants previously were charged by indictment in connection with a conspiracy to defraud the FDA, distribute unapproved new drugs, and conspiracy to distribute controlled substances. One other defendant pleaded guilty in 2019, and the remaining defendants are set for trial in October.

The indictment charging the remaining defendants is merely an allegation, and the defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.

Trial Attorneys Alistair Reader and Steven Gripkey, Senior Litigation Counsel David Frank, and Assistant Director John W. Burke of the Justice Department’s Consumer Protection Branch are prosecuting the case with assistance from the U.S. Attorney’s Office for the Southern District of Florida.

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Author: Editor
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